Folates

Please note, this OEL/ADE monograph also applies to Folate sodium (CAS RN 6484-89-5), Folcysteine (CAS RN 8064-47-9), Folic acid potassium salt (CAS RN 36653-55-1), Folic acid dihydrate (CAS RN 75708-92-8), Calcium folate (CAS RN 78168-16-8), Levomefolate glucosamine (CAS RN 1181972-37-1), Folitixorin (CAS RN 3432-99-3), Folitixorin calcium (CAS RN 133978-75-3), Folitixorin sodium (CAS RN 133978-76-4), Arfolitixorin monosulfate (CAS RN 149930-93-8), and Arfolitixorin hemisulfate (CAS RN 1654736-73-8). Folate is the generic name for a number of compounds having a similar activity as folic acid (pteroylglutamic acid (PGA)), being involved in single carbon (C1-) transfer reactions. Folic acid (PGA) is a synthetic folate compound used in food supplements and in food fortification because of its stability; it becomes biologically active after reduction. Natural (dietary) folates are mostly reduced folates, derivatives of tetrahydrofolate (THF), such as 5-methyl-THF (5- MTHF), 5-formyl-THF and 5,10-methylene-THF, and exist mainly as pteroylpolyglutamates, with up to nine additional glutamate molecules attached to the pteridine ring.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

Folates

CAS Registry Number:
59-30-3
Trade names:
Axcel®, Duafolic®, Natafolik®
Cost:
$679 USD

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Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

  • The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
  • A listing of all cited references utilized in the derivation of the OEL and ADE
  • An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

  • Fully documented. 10-12 pages in length, with calculations and cited references.
  • Save time! Unsurpassed delivery with instant download.
  • Save money. Similar documents cost 5-12 times as much.
  • Stay current. Automatic notification of revisions.

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To order an OEL/ADE monograph for Folates, just click the ADD TO CART button.

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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.
  • K. Rosenthal
  • Director of Manufacturing